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CTRI Number  CTRI/2026/01/100214 [Registered on: 02/01/2026] Trial Registered Prospectively
Last Modified On: 26/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Other 
Public Title of Study   A clinical study to see whether applying Himawan Agad on the skin can help prevent nerve problems like numbness, tingling, and pain caused by Paclitaxel chemotherapy. 
Scientific Title of Study   Open Labelled Passive Controlled Clinical Evaluation of External Application of Himawan Agad as Prophylaxis in Paclitaxel Chemotherapy-Induced Peripheral Neuropathy (PIPN) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Poorva Padmanabha Gogate 
Designation  PG Scholar 
Affiliation  Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital 
Address  Visha Chikitsa OPD Department of Agadtantra Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital Dhankawadi Pune

Pune
MAHARASHTRA
411043
India 
Phone  8275764426  
Fax    
Email  poorvagogate0401@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasad Namewar 
Designation  Professor, Head of Department 
Affiliation  Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital 
Address  Visha Chikitsa OPD Department of Agadtantra Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital Dhankawadi Pune

Pune
MAHARASHTRA
411043
India 
Phone  9226269869  
Fax    
Email  prasad.namewar@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Prasad Namewar 
Designation  Professor, Head of Department 
Affiliation  Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital 
Address  Department of Agad tantra Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital Dhankawadi Pune


MAHARASHTRA
411043
India 
Phone  9226269869  
Fax    
Email  prasad.namewar@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Poorva Gogate 
Address  Department of Agad tantra Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital Dhankawadi Pune Maharashtra India 411043 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Poorva Padmanabha Gogate  Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital   Bharati Vidyapeeth Deemed to be University Visha Chikitsa OPD no 14 Katraj Dhankawadi Pune 411043
Pune
MAHARASHTRA 
8275764426

poorvagogate0401@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY) PUNE COLLEGE OF AYURVED PUNE SATARA ROAD PUNE411043 INSTITUTIONAL ETHICAL COMMITTEE [BV(DU)COA-IEC]  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G620||Drug-induced polyneuropathy. Ayurveda Condition: VATAVYADHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-viShopakramaH, विषोपक्रमः (Procedure Reference: Y T Acharya, Procedure details: Positioning The patient should sit or lie in a comfortable position exposing Palms and soles Application Apply a uniform layer (about 3 mm thick) of the prepared lepa over the palms and soles Cover the area with sterile gauze if needed to keep the paste intact and prevent dripping Avoid massage or rubbing Contact Duration Leave the lepa in place till it dries Removal Gently wipe off the lepa with a soft cotton cloth soaked in lukewarm water Dry the area with a clean towel Frequency of Application Twice daily)
(1) Medicine Name: Himawan Agad, Reference: Himawan Agad has been mentioned in Ashtanga Hriday Uttarsthana 36th adhyay, (Sarpavisha Pratishedha Adhyay). , Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Duration: 12 Weeks
2Comparator Arm (Non Ayurveda)-NILNIL
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients having Paclitaxel as their main chemotherapy drug
Patients planned for 12 weeks of paclitaxel chemo cycle
Age 18 to 70 years 
 
ExclusionCriteria 
Details  Patients having Diabetic Neuropathy
Patients having Peripheral Neuropathy but with acute systemic adverse effects 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significantly reduce incidence and severity of PIPN  Day0 Day14 Day28 Day35 Day56 Day70 Day84 
 
Secondary Outcome  
Outcome  TimePoints 
Provide symptomatic relief from burning tingling and numbness in case of
development of PIPN
Improve nerve conduction and restore neurological functions 
Day0 Day14 Day28 Day35 Day56 Day70 Day84 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   06/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Brief Summary

Cancer is commonly treated with chemotherapy, but these medicines often cause side effects that reduce a patient’s comfort and quality of life. Paclitaxel, a widely used chemotherapy drug, is very effective against cancers like breast, ovarian, and lung cancer, but it frequently causes peripheral neuropathy a condition marked by tingling, burning, pain, numbness, and loss of sensation in the hands and feet. These symptoms may become severe or long-lasting, forcing doctors to reduce or stop chemotherapy. Himawan Agad, a classical Ayurvedic formulation described in Ashtanga Hridaya, is traditionally indicated for conditions involving burning, pain, inflammation, and Vata-Pitta dominance. When used externally as Himawan Agad Lepa, mixed with honey, it contains herbs known for pain relief, burn-relieving, anti-inflammatory, neuroprotective, and tissue-healing actions. This study is designed as an open-label passive-controlled clinical evaluation to assess the preventive role of Himawan Agad Lepa in patients receiving Paclitaxel chemotherapy. By applying the formulation externally, especially over vulnerable areas like the lower limbs, the therapy aims to reduce the onset and severity of neuropathic symptoms. The study seeks to establish a safe, cost-effective, and integrative Ayurvedic approach for preventing chemotherapy-induced peripheral neuropathy and improving patient comfort and treatment continuity.


 
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